Mobile Therapy for Mental Illness in Homeless-Experienced Veterans

Overseen By Michael F Green, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological disorder, Head injury, IQ < 70, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help veterans with serious mental illness who have experienced homelessness feel more connected to their communities. It tests a combination of Motivational Interviewing and Cognitive Behavioral Therapy (MI-CBTech) delivered through both in-person and mobile phone sessions. Participants will be divided into two groups: one will receive this new therapy, while the other will try mindfulness training. Veterans who have lived in a VA mental health residential program and have a history of homelessness may be suitable candidates. As an unphased trial, this study offers veterans a unique opportunity to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the focus is on behavioral therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) is generally safe for treating mental health issues. These methods have proven effective for problems like substance use and depression. The MI-CBTech trial uses mobile technology to increase accessibility by allowing some sessions on a phone or smart device.

No evidence indicates serious safety concerns with either MI or CBT. People typically handle these therapies well. They involve discussing and analyzing problems, eliminating the need for surgery or medication, which makes them safer than treatments involving drugs.

In summary, both MI and CBT are recognized for their safety in treating mental health issues. The technology in MI-CBTech aims to enhance convenience without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for mental illness in homeless-experienced veterans because they blend traditional therapeutic methods with modern technology. Unlike standard care options, which often require regular in-person visits, the MI-CBTech treatment utilizes mobile devices to deliver a combined approach of Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), making therapy more accessible and flexible for participants. Additionally, the Mindfulness control arm offers a unique mix of supportive therapy and mindfulness training, also available through mobile platforms, which could enhance engagement and efficacy. These innovative delivery methods could significantly increase treatment accessibility and adaptability, potentially leading to better outcomes for a population that faces unique challenges in accessing consistent mental health care.

What evidence suggests that this trial's treatments could be effective for improving community integration in Veterans with serious mental illness?

This trial will compare two interventions: MI-CBTech and a Mindfulness control. Studies have shown that combining Motivational Interviewing (MI) with Cognitive Behavioral Therapy (CBT) can effectively improve mental health. In this trial, the combination is called MI-CBTech and helps boost motivation and commitment to therapy. Research indicates that MI-CBTech has successfully treated various conditions, including substance use disorders. While CBT alone is a proven method for managing mental health issues, adding MI increases engagement and effectiveness. This approach aims to help Veterans with serious mental illness who have experienced homelessness by improving their ability to integrate into the community. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy M Jimenez, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18-65 with serious mental illnesses like schizophrenia or mood disorders, who have experienced homelessness and are currently in a VA residential program. They must speak English well enough to participate and be medically stable. Those with significant neurological issues, severe head injuries, very low IQ, or recent substance abuse problems cannot join.

Inclusion Criteria

Veterans currently residing at the VA Greater Los Angeles Mental Health Residential Rehabilitation Treatment Program (Domiciliary)

Medically and clinically stable (i.e. able to participate in and complete assessments and intervention)

My medical records confirm I have a psychotic illness.

Exclusion Criteria

Evidence of IQ < 70 or developmental disability

I have had a serious head injury with significant effects.

I have a significant neurological condition like epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo interviews and assessments of cognitive ability at an in-person baseline visit

1 day

1 visit (in-person)

Treatment

Participants receive an 8-week intervention combining in-person sessions and remote elements via mobile phone

8 weeks

3 visits (in-person), remote check-ins at weeks 2, 4, and 6

End of Treatment Assessment

Participants undergo a repeat assessment of symptom ratings and community functioning

1 day

1 visit (in-person or remote)

Follow-up

Participants complete a final evaluation of symptoms ratings and community functioning as well as an exit interview

8 weeks after end of treatment

1 visit (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• MI-CBTech
• Mindfulness control

Trial Overview The study tests MI-CBTech—a mix of Motivational Interviewing and Cognitive Behavioral Therapy delivered through in-person sessions and mobile phones—to help integrate homeless-experienced Veterans with mental illness into the community. A control group receives mindfulness training via phone. Participants are randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: MI-CBTech Experimental Treatment 1 Intervention

An 8-week experimental intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). The format of the intervention will be a combination of in-person sessions and remote elements (together called MI-CBTech) delivered via mobile phone or other smart device.

Group II: Mindfulness control Active Control 1 Intervention

An 8-week active control intervention that combines supportive therapy and mindfulness training. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone or other smart device.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The beta test of the Mind Guide mobile health app, involving 16 post-9/11 veterans with PTSD and alcohol use disorder, showed significant reductions in PTSD symptoms and alcohol-related issues, indicating its potential efficacy as an intervention.

The app demonstrated promising effects on related factors such as craving, perceived stress, and emotion regulation, suggesting that mindfulness-based techniques may help veterans manage their conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial. Davis, JP., Pedersen, ER., Borsari, B., et al.[2023]

A study involving 163 combat-wounded veterans showed that a significant majority expressed interest in participating in an online mindfulness-based treatment to address their mental health and substance use issues, with 59.5% preferring online options.

Veterans with multiple health problems and lower self-compassion were particularly interested in this treatment, indicating a high need for effective mental health interventions in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Mental Health Problems and Willingness to Participate in a Mindfulness Treatment: An Examination among Veterans Injured in Combat. Bravo, AJ., Witkiewitz, K., Kelley, ML., et al.[2023]

A pilot study involving 30 U.S. Veterans evaluated the Mindset mobile app, which uses heart rate monitoring to promote e-therapy, and found significant reductions in PTSD, anxiety, and depression symptoms after approximately one month of use.

Participants reported high satisfaction with the Mindset app, although they experienced frustration with the associated smartwatch, indicating that while mobile health tools can be effective, usability issues need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving mental health in U.S. Veterans using mHealth tools: A pilot study. Latour, C., O'Byrne, L., McCarthy, M., et al.[2021]

A study of 98 veterans with psychiatric disorders showed that while attendance in mindfulness-based cognitive therapy (MBCT) was low (average of 4.87 out of 8 sessions), those who attended had a significant reduction in psychiatric hospitalizations after the intervention.

Despite the challenges in implementing MBCT due to high dropout rates, the results suggest that MBCT could be beneficial for veterans at high risk for psychiatric hospitalization, warranting further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement and Outcomes of Mindfulness-Based Cognitive Therapy for Veterans with Psychiatric Disorders. Marchand, WR., Yabko, B., Herrmann, T., et al.[2020]

The tailored mindfulness-based intervention (MBI) showed significant improvements in personal recovery, mindfulness, self-compassion, and resilience among participants with mental illness during the COVID-19 pandemic, with benefits maintained one month after the intervention.

Participants in the MBI group reported high acceptability of the program, while those in the relaxation training group experienced a decline in resilience over time, highlighting the potential advantages of MBI for long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial Among People Recovering from Mental Illness: A Tailored Mindfulness-Based Intervention versus Relaxation Training. Cheng, YTD., Young, KWD., Carlbring, P., et al.[2023]

The FOCUS mHealth intervention was found to be feasible and highly acceptable among 17 veterans with serious mental illnesses, with 94% of participants willing to recommend it to others, indicating strong user satisfaction.

Participants experienced small improvements in self-assessed recovery, auditory hallucinations, and quality of life over the 1-month trial, suggesting preliminary effectiveness of the intervention in enhancing mental health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FOCUS mHealth Intervention for Veterans With Serious Mental Illness in an Outpatient Department of Veterans Affairs Setting: Feasibility, Acceptability, and Usability Study. Buck, B., Nguyen, J., Porter, S., et al.[2022]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

The Home-Based Telemental Health (HBTMH) program successfully delivered mental health services to rural veterans using webcams and secure software, demonstrating high levels of satisfaction and perceived safety among the 40 veterans surveyed.

Veterans participating in the HBTMH program had fewer missed appointments compared to traditional clinic-based mental health services, indicating improved access and engagement in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting veterans where they're @: a VA Home-Based Telemental Health (HBTMH) pilot program. Shore, P., Goranson, A., Ward, MF., et al.[2022]

A study involving 177 participants found that an internet-based mindfulness and metta-based trauma therapy (MMTT) was perceived as a credible and helpful intervention for improving self-regulation and reducing symptoms of PTSD, anxiety, and depression.

Participants rated guided and non-guided meditation practices as more beneficial than journaling, suggesting that MMTT could serve as a valuable adjunct to traditional treatments for trauma and stress-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and Metta-based Trauma Therapy (MMTT): Initial Development and Proof-of-Concept of an Internet Resource. Frewen, P., Rogers, N., Flodrowski, L., et al.[2021]

Citations

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The outcome of integrated motivational interviewing and ... The authors aimed to evaluate the outcome of combined motivational interviewing and cognitive-behavioral therapy (MICBT) for substance use disorder

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Integrating the motivational interviewing approach with ... Cognitive behavioral therapy is an evidence-based intervention approach that has proven successful across a variety of conditions and has ...

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Study Details | NCT06138054 | MI-CBTech: A Mobile ... Studies integrating Motivational Interviewing (MI) with CBT have shown positive results for a variety of disorders, including serious mental illness. MI ...

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The effectiveness of psychosocial interventions for reducing ... Individual psychosocial interventions can also be effective: cognitive behavioural therapy (CBT) reduces problematic substance use and motivational interviewing ...

8. withpower.com withpower.com/trial/phase-schizophrenia-11-2023-9bbba

Mobile Therapy for Mental Illness in Homeless ... The MI-CBTech treatment is unique because it combines motivational interviewing and cognitive behavioral therapy with mobile health (mHealth) technology ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200683/

Motivational Interviewing: An Evidence-Based Approach for ... Motivational interviewing (MI) is a technique that has been specifically developed to help motivate ambivalent patients to change their behavior.

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The effectiveness of psychological interventions for people ... A meta-analysis was performed on data from 22 studies investigating outcomes of substance use, abstinence, anxiety, depression and PTSD.